Medical Device Consulting
Your Partner In Quality Systems
Bringing your medical device to market is a complex process. Partnering with a highly experienced, focused, and flexible group of experts for the development process can mean the difference between getting it done and getting it done with the right medical device quality system. And that can mean the difference between failure of your product, and sometimes your company — and enormous success.
Medical Device Consulting Expertise
Through independent auditing directly to the standards, due diligence is automatically performed at every phase of the process. Don’t yet have a quality system? You can rely on ours while in the process of achieving your own. Or, if you prefer, we can work with your team to develop your own quality system in a cost effective manner. No matter the quality system issue we can work with you to develop a remediation plan to best fit your needs.
We can perform a gap analysis of your existing project to come up with the most efficient path to prepare for your submission.
Medical Device Consulting Services Include:
- Quality system review, then develop and implement a remediation plan, if applicable
- Complete Quality System development
- Risk assessment & hazard analysis consulting
- Process validation – Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)
- Part 11 & HIPAA Compliance review
- Safety assurance cases
- Software quality assurance
- Training of your employees in FDA or ISO approved Medical Device Standards, including development methodologies and processes
- FDA, ISO and CE medical device safety consulting
- Design documentation services
Whether we do the work under your quality system or our ISO 13485 registered quality system, we’ll make sure you meet or exceed quality systems requirements.